A Study Evaluating the Efficacy of Fluocinonide Cream 0.1% (Vanos) in Subjects With Atopic Dermatitis

NCT01049243 | Completed Phase 4 Results

• 1 other identifier: IRB00006468
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to better understand how fluocinonide cream 0.1% (Vanos®) works when people use it to treat atopic dermatitis for just a few days.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; Open-Label; Topical; Cream; Eczema; Vanos

Outcome Measures

Primary Outcomes (1)

• Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 2/3.

  Use of the Investigator's Global Assessment (IGA) score, a subjective scale measuring disease severity. Based on a 6-point scale from 0 (completely clear) to 5 (very severe). Defined score of 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe.

  Baseline to 3 days

Secondary Outcomes (1)

• Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 14.

  Baseline to 14 days

Study Arms (1)

Fluocinonide Cream 0.1%

OTHER

Fluocinonide Cream 0.1% open label

Drug: Fluocinonide Cream 0.1%

Interventions

Fluocinonide Cream 0.1% DRUG

0.1% Cream, One Application, Twice Daily, 14 Days

Also known as: Vanos

Fluocinonide Cream 0.1%

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female with mild to severe atopic dermatitis, 12 years of age or older, that agree to participate and provide written consent (and assent if applicable)
• Have an Investigator Global Assessment of mild to severe atopic dermatitis (IGA rating of 2 - 4 in the Investigator Global Assessment (Appendix B))
• Percentage of overall body surface are of involvement (BSA) must be ≥2%
• Women of child bearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control

You may not qualify if:

• Use within 4 weeks of baseline of systemic anti-inflammatory medication, which may influence study outcome, such as systemic corticosteroids
• Application or use within 2 weeks of baseline of topical corticosteroid medications or topical anti-inflammatory medication, which may influence study outcome
• Presence of a concurrent medical condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments
• Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study
• Amount of disease involvement that would require \>60 gm of cream in a 1 week period
• Subjects with known allergy or sensitivity to topical Vanos™ cream or components
• Pregnant women and women who are breastfeeding are to be excluded. Women of childbearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Medicis Pharmaceutical Corporation: collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

Fluocinonide

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fluocinolone Acetonide; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Steven Feldman, MD, PhD
• Organization: Wake Forest University Health Sciences

sfeldman@wfubmc.edu

336-716-1877

Study Officials

• Steven Feldman, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 14, 2010
• Study Start: March 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: October 1, 2009
• Last Updated: August 1, 2018
• Results First Posted: March 5, 2013

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)